Lilly Statement On STAR

Main Category: Women's Health / Gynecology
Also Included In: Bones / Orthopedics;  Breast Cancer;  Clinical Trials / Drug Trials
Article Date: 18 Apr 2006 - 0:00 PDT

email to a friend   printer friendly   opinions  

Eli Lilly and Company today issued the following statement in response to the release of high-level results of the Study of Tamoxifen and Raloxifene (STAR) trial, announced by the National Surgical Adjuvant Breast and Bowel Project (NSABP). The trial was funded by the National Cancer Institute (NCI) and conducted by researchers with the NSABP.

"The NSABP's STAR study represents an important milestone in cancer research," said Steven Paul, M.D., executive vice president of science and technology, Lilly. "We are pleased with the STAR results, which add to the growing body of scientific knowledge about the potential for therapies to reduce breast cancer risk."

The STAR data, coupled with data from the Raloxifene Use for the Heart (RUTH) trial, represent important information, which Lilly plans to use for a submission to the U.S. Food and Drug Administration (FDA) in support of an indication for Evista(R) (raloxifene HCl) for the reduction of invasive breast cancer risk in postmenopausal women.

Importantly, Evista is currently marketed in the U.S. for the prevention and treatment of osteoporosis in postmenopausal women. Raloxifene is not approved by the FDA for preventing or reducing the risk of cardiovascular disease or invasive breast cancer.

RUTH is a multi-national, double-blind, placebo-controlled study with primary endpoints of invasive breast cancer risk and cardiovascular risk reduction. Lilly recently has announced preliminary results from RUTH. Final results from that study are being analyzed and will be presented later this year.

RUTH and STAR, combined with data from Multiple Outcomes of Raloxifene Evaluation (MORE) and Continuing Outcomes Relevant to Evista (CORE) would be included in a potential supplemental new drug application filing package.

Important Safety Information

EVISTA is not for everyone. If you are or still can become pregnant, are nursing, have severe liver problems, or have had blood clots that required a doctor's treatment, you cannot take EVISTA. An infrequent but serious side effect of EVISTA is blood clots in the veins -- being immobile for a long time may add to the risk.

EVISTA does not increase or decrease the incidence of heart attack, stroke, cardiovascular death, or overall death. In a study of postmenopausal women at high risk for cardiovascular disease taking EVISTA, there was no increase in the incidence of stroke; however, there was an increase in the incidence of death due to stroke. If you have had a stroke or have a history of other significant risk factors for stroke, such as a mini-stroke (TIA/transient ischemic attack), or a type of irregular heartbeat (atrial fibrillation), you should discuss with your doctor or healthcare professional the risks versus benefits of taking EVISTA.

The most commonly reported side effects are hot flashes and leg cramps. Side effects with EVISTA are usually mild, and most women don't find them serious enough to stop taking it.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com.

For more information about Evista, log onto http://www.evista.com.

For more information on Lilly's oncology portfolio, log onto http://www.lillyoncology.com

This press release contains forward-looking statements about the safety and efficacy of Evista and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research and commercialization. There is no guarantee that Evista will be approved for the reduction of breast cancer risk or that it will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

• Additional
• References
• Citations